N/A
N=32
Effects of Cataract Extraction Surgery and Limbal Relaxing Incision on Corneal Sensation and Dry Eye
Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT01161771 ↗Enrolled (actual)
32
Serious AEs
—
Results posted
Jul 2012
Primary outcome: Primary: The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured — 13; 13; 21.7; 13 Percentage of Subjects
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Cataract Surgery and Limbal relaxing incision (Procedure)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured |
13; 13; 21.7; 13; 8.7 | — |
| SECONDARY Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score at Month 3 |
15.739; -9.826 | — |
| SECONDARY Change From Baseline in Corneal Staining at Month 3 |
0.652; 0.261 | — |
| SECONDARY Change From Baseline in Conjunctival Staining at Month 3 |
1.087; -0.174 | — |
| SECONDARY Change From Baseline in Tear Break-Up Time at Month 3 |
16.4; -3.71 | — |
| SECONDARY Change From Baseline in Schirmer's Test at Month 3 |
11.091; 0.909 | — |
Summary
This is a multicenter evaluation of the effects of the cataract extraction and limbal relaxing incisions (LRI) on corneal sensation and dry eye signs and symptoms.
Eligibility Criteria
Inclusion Criteria
- Patient scheduled to undergo clear corneal cataract extraction with planned limbal relaxing incision for correction of a corneal astigmatism
Exclusion Criteria
- Uncontrolled systemic disease
- Have undergone refractive surgery or any surgery involving a limbal or corneal incision
- Use of topical cyclosporine (Restasis) within three months of baseline/randomization visit
- Temporary or permanent occlusion of the lacrimal puncta
Data sourced from ClinicalTrials.gov (NCT01161771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.